Simple & Safe Implantable Device for Treatment of Gastroesophageal Reflux Disease

描述（由申请人提供）：该项目的最终目标是开发一种简单的腹腔镜产品（Partial Cuff）来治疗胃食管反流病（GERD）或胃酸反流。在4000万美国胃食管反流患者中，至少有450万人需要额外的或替代的药物治疗，而另外400万人对他们的药物治疗方案不满意。虽然眼底复制手术是唯一的治疗方法，但其严重性、风险和生理干扰是99%以上患者采用的障碍。胃食管反流是所有胃肠道疾病中最昂贵的一种，每年仅在处方药上的花费就超过60亿美元，而且这个数字还在增长。由于这个市场的规模，大大小小的公司已经开发了许多侵入性较小的，主要是经口腔的内窥镜手术。他们的目的是达到与手术相同的目的，增加食管下括约肌（LES）的约束。大多数这些程序代表了重大的技术挑战，临床结果不太令人满意，没有一个被广泛采用。部分袖口设计用于腹腔镜下放置，只需点击其特殊放置手柄即可简单直接放置在食道上，从而避免了将胃段包裹在食道上的繁琐手术。一旦应用，形状和灵活的部分袖带包裹食道，并在LES的一部分上立即施加约束，类似于Toupet部分底复制程序。这使得LES不受约束的部分仍然能够自然打开，例如在吞咽或打嗝时。当组织在大约8周内生长完成时，部分袖带成为LES壁的整体，进一步赋予其约束作用。这种简单和直接的治疗程序最大限度地减少了困扰当前手术和经口手术的挑战。拟议的部分袖带是为了改善生活质量，减轻数百万胃反流患者对药物的终身依赖。这反过来又将导致国家保健费用的大幅减少。对于第一阶段，我们建议将我们的概念推进到工作设备。他们将在实验台上的模型和在体内的猪研究中进行测试，以验证工作假设，评估生物相容性以及设备是否保持原位。初步的解剖和病理生理学工作已经完成，包括对尿道失禁类似模型的有限元分析。设备系统的三个部分将按照上述方式进行设计、制造、组装和测试。完成第一阶段将使我们能够在临床可行性研究中进一步验证该研究，并满足FDA第二阶段许可的要求。

DESCRIPTION (provided by applicant): The ultimate goal of this project is to develop a simple laparoscopic product (Partial Cuff) to treat gastroesophageal reflux disease (GERD) or acid reflux. Of the 40 million U.S. GERD sufferers currently manage their symptoms by life-time medications, at least 4.5 million will require additional or alternative remedies, while another 4 million are not satisfied with their medication regimen. Though fundoplication surgery is the only cure, its severity, risks and physiological perturbations are barriers to adoption by over 99% of patients. GERD represents the most expensive of all of the GI diseases, with over $6 billion spent annually just in prescription medications alone, and this number is growing. Because of the size of this market, many less invasive and mostly trans-oral endoscopic procedures have been developed by large and small companies. They aim to achieve the same objective as surgery in increasing the constraints of the lower esophageal sphincter (LES). Most of these procedures represent significant technical challenges with less than satisfactory clinical outcomes and none of them have been widely adopted. Partial Cuff is designed to be placed laparoscopically, simply and directly onto the esophagus with a click of its special placement handle, thereby circumventing the cumbersome surgery of wrapping a segment of the stomach over the esophagus. Once applied, the shaped and flexible Partial Cuff hugs the esophagus and imparts an immediate constraint over a portion of the LES similar to the Toupet partial fundoplication procedure. This allows the unconstrained portion of the LES still be able to open naturally, such as during swallowing or burping. When tissue ingrowth completes in about 8 weeks, the Partial Cuff becomes integral in the LES wall, further imparting its constraining utilit. This simple and direct treatment procedure minimizes challenges plaguing current surgeries and trans- oral procedures. The proposed Partial Cuff is to improve the quality of life and mitigate life-long dependence on medications for millions of GERD sufferers. This in turn will result in a substantial reduction in national healthcare costs. For Phase I, we propose to advance our concept to working devices. They will be tested on a bench top model and in an in vivo pigs study to verify the working hypothesis, assess biocompatibility and whether the device stays in place. Preliminary work has been completed on the anatomy and pathophysiology of the LES including a finite element analysis on an analogous model of urethral incontinence. The three parts of the device system will be engineered, made, assembled and tested as stated above. Completing this Phase I will allow us to further validate this in a clinical feasibility stuy and to fulfill requirements towards FDA allowance in Phase II.